Director, CDx Regulatory Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• The Director, CDx Regulatory Consultant will leverage extensive expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to provide guidance to pharmaceutical, biotechnology, and diagnostic clients regarding the development, clinical trial utilization, approval, and lifecycle management of companion diagnostics.

• Transform intricate FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that facilitate Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.

• Act as the CDx regulatory subject matter expert for the strategic positioning of client programs.

• Proactively assess client needs by comprehending the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.

• Lead consulting engagements with pharmaceutical clients to formulate global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-driven timelines that align with clinical trial execution, regulatory authorization, and commercialization goals.

• Collaborate cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure that CDx development activities are synchronized with overall program timelines and regulatory expectations.

⛳️ Requirements

• A Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be taken into account.

• At least 5 years of relevant consulting experience with a primary emphasis on IVD, companion diagnostics, clinical trial assays, or precision medicine regulatory affairs.

• Minimum of 7 years of experience within an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting setting.

• Direct experience collaborating with diagnostic manufacturers/labs and pharmaceutical sponsors to formulate global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.

• Excellent written and verbal communication skills, with a proven ability to translate complex CDx regulatory requirements into clear, actionable recommendations for clients and cross-functional teams.

• Strong scientific and analytical capabilities, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of the CDx regulatory strategy.

• Ability to address complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions.

• Strong leadership, team-building, and interpersonal skills, with the ability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial functions.

🏝️ Benefits

• Discretionary annual bonus

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation